ISO 13485 Medical Devices
What is ISO 13485?
ISO 13485:2016 is a valued investment in any organizations within the medical devices industry. The standard is recognized globally and can deliver more effective and efficient processes, streamline operations & working practices, encourage communication, consultation and awareness and enhance the overall quality and management performance of your company. It is built from the principles of ISO 9001, but with the additional industry-specific guidelines covering the life cycle of a medical device, from initial conception to production and post-production, including final decommission and disposal and removal of those parts that are not relevant to this sector.
This management system framework is designed to help organizations ensure that they meet the needs and expectations of customers and other stakeholders whilst meeting statutory and regulatory requirements by establishing QMS practices that consistently yield safe and effective medical devices.
ISO 13485:2016 can help your organization continually improve in all aspects of quality management including customer service & satisfaction, performance monitoring and measuring, supplier & service provider management, design & development of products & services and much more within your specialist area of the medical devices industry.
Benefits of ISO 13485:2016:
- Increased operational effectiveness and efficiency.
- Client and potential client / customer confidence in your organizations ability to deliver quality products, services and meet the needs and expectations of stakeholders and contracts.
- Increased revenue and profits through streamlined efficiency in processes and operations.
- Excellent customer satisfaction.
- Better supplier & service provider relationships.
- Increased tender capabilities.
- Proactive response.
- Increased transparency and traceability.
- Promotion of a positive culture across all levels of the business with increased communication and awareness.
- International recognition.
- Specific to your industry sector.
How can we support?
We build ISO management systems as unique as our clients and we are proud of the relationships we build together along the way. Get in touch with our ISO team today and let us partner you on your ISO implementation journey. We are proud of our ISO team, their knowledge and experience working nationally and internationally with our clients supporting implementation through to successful certification.
We deliver a different level of support working together with our clients, building bespoke management systems that truly fit the scope of their business, designed for continual improvement and delivering results. We educate your team as we move through the process and we deliver the Stage 1 and Stage 2 certification audits with you to ensure successful achievement.
Our team implement single and combined integrated management systems with a 100% success rate that we are proud of. We are equally proud of the relationships we build with our clients and our 97% retention rate for ongoing support after successful certification to help ensure that you retain certification and your systems continue to evolve with your strategic direction and growth.